BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Adhesive Internal Use

    PMA: P220024 · Decision Jun 2, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Tissue Adhesive Internal Use
    Trade Name
    LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
    PMA Number
    P220024
    Device Class
    FDA Class 3
    Product Code
    PLJ
    Generic Name
    Tissue adhesive internal use
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 2, 2023
    Date Received
    October 27, 2022
    Expedited Review
    N
    Docket Number
    23M-2807

    Advisory Committee Statement

    Approval for The LIQUIFIX FIX8 Hernia Mesh Fixation device is intended for use in laparoscopic surgical repair of groin (inguinal and femoral) hernias, achieved through the fixation of prosthetic polypropylene or polyester mesh to the abdominal wall and the approximation of the peritoneum.The LIQUIFIX Precision Open Hernia Mesh Fixation device is intended for use in open surgical repair of groin (inguinal and femoral) hernias, achieved through the fixation of prosthetic polypropylene or polyester mesh to the abdominal wall.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PLJ Tissue Adhesive Internal Use